ArticleTrials2022
Primary care disease management for venous leg ulceration-study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126).
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Implementing a primary care disease management concept for venous leg ulceration: findings of a mixed-methods process evaluation in the Ulcus Cruris Care trial.BMC health services research · 2026Trial
- Treating Venous Leg Ulcers in Primary Care: The Cluster-Randomized Ulcus Cruris Care Trial.Deutsches Arzteblatt international · 2026Trial
- Developing an Evidence-Based and Patient-Centred Care Concept to Address Deficits in German Primary Care of Venous Leg Ulcers: Results of an Expert Survey Within the ULCUS CRURIS CARE Project.International wound journal · 2026Article
- Pilot Implementation of a Primary Care Disease Management Concept for Venous Leg Ulceration: Results of a Mixed-Methods Process Evaluation.Healthcare (Basel, Switzerland) · 2024Article
- A Combined Telemedicine and Ambulatory Wound Care Team Intervention for Improving Cross-Sector Outpatient Chronic Wound Management: Protocol for the Mixed Methods TELE-AMBUS Research Project.JMIR research protocols · 2024Article
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Authors and funding
11 authors.
Funding
Abstract
backgroundVenous leg ulcers (VLU) have a prevalence of 1-2% in developed countries, and affected patients are severely and long-term impaired in daily activities, work, and social participation. Evidence-based outpatient treatment based on compression therapy is frequently not implemented. The "Ulcus Cruris Care" project was established to develop a disease management concept to improve outpatient treatment for patients with VLU in German primary care. For this purpose, a multifaceted intervention was conceived consisting of an online training for general practitioners and medical assistants, standardized treatment recommendations, e-learning and print-based information for patients, and a software support for case management. The main aims of the Ulcus Cruris Care intervention are to promote standardized treatment according to current scientific knowledge, to facilitate case management for VLU patients exerted by medical assistants, and to support patient education and participation in the treatment process. The UCC trial was designed to evaluate the effectiveness of the Ulcus Cruris Care intervention.
methodsThe UCC trial is a prospective cluster-randomized controlled multicenter trial. Fifty GP practices are intended to be recruited and randomized 1:1 to intervention or control arm. Patients with venous leg ulcers will be recruited by participating GP practices, to include a total of 63 patients in each arm. The primary outcome is time to ulcer healing. Secondary outcomes comprise number and sizes of ulcers, recurrence, pain intensity according to the visual analog scale, health-related quality of life according to EQ-5D-5L, depressiveness according to Patient Health Questionnaire (PHQ-9), patient satisfaction according to the Patient Assessment of Chronic Illness Care (PACIC-5A) query, and adherence to VLU treatment. The outcome analysis of the UCC trial is accompanied by a health economic analysis and a process evaluation. DISCUSSION: The UCC trial will evaluate whether the Ulcus Cruris Care intervention may lead to faster wound healing, higher health-related quality of life, and lower use of medical resources. If the intervention turns out to have a positive impact on assessed outcomes, comprehensive implementation in primary care may be considered.
trial registrationThe trial protocol (version 1 as of July 19, 2021) has been registered in the German Clinical Trials Register on August 30, 2021 ( DRKS00026126 ).
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